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Almonds, Gut Microbiome and Kids

11. september 2026 oppdatert av: Ravi Nagpal, Florida State University

Nutritional Impact of Almond Butter on Gut Microbiome and Cardiometabolic Health in School-Aged Children: A Novel and Timely Pilot Randomized Controlled Trial

This 8-week parallel-arm randomized controlled trial (N=70; ages 6-13) will determine the impact of daily almond butter consumption on gut microbiome composition and function, intestinal barrier integrity, and cardiometabolic health in school-aged children. Participants will be randomized to either a once-daily snack of personalized-portion almond butter (ALB; 16g, Creamy Natural Almond Butter) or an isocaloric nut-free chocolate spread control (CTL; 16g, Cadbury Milk Chocolate), each served on two plain unsalted saltine crackers, added to their habitual diet. The primary outcomes include oro-gut microbial composition and diversity, gut microbial functional capacity and metabolomics (SCFAs, bile acids, amino acid metabolites), and intestinal barrier integrity. Secondary outcomes include fasting cardiometabolic markers, systemic inflammation, appetite-regulatory and metabolic hormones, and sleep-related biomarkers. Feasibility, adherence (weekly logs; serum α-tocopherol), and precision nutrition potential will also be assessed, with stratified analyses by age, sex, BMI, ethnicity, and pubertal stage.

This pilot trial will generate the first multi-omics characterization of almond butter's effects on the gut-immune-metabolic axis in children.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Rayven Nairn, MS, RD
  • Telefonnummer: 850-644-1829
  • E-post: rsn25b@fsu.edu

Studiesteder

  • Forente stater
    • Florida
      • Tallahassee, Florida, Forente stater, 32306
        • Rekruttering
        • The Gut Biome Lab
        • Ta kontakt med:
        • Underetterforsker:
          • Cole Patoine, MS, RD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Enrolled in elementary or middle school (grades 1-8)
  • Aged 6-13 years old
  • Ability to speak and read in English

Exclusion Criteria:

  • Intake of antibiotics in the last 3 months
  • Intake of pre/pro/postbiotics in the last 3 months

  • Food allergy to study foods

    ◦ Any allergy to nuts or almonds

  • Any allergy to the isocaloric snack (chocolate or wheat)
  • Regular consumption of nuts or almonds greater than 2 servings / week
  • Gastrointestinal disease (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, gastroesophageal reflux disease), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C > 9%).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Kontroll snack -tilstand
Kontroll (CTL) -gruppe: Denne tilstanden inkluderer et normalt kosthold supplert daglig med en isokalorisk mengde av en nøttefri, vegetabilsk oljebasert sjokoladespredning (Cadbury melkesjokolade) også klemt mellom to vanlige usaltede saltkrekker (usaltede topper premium saltkrekker), med den samme 16G-grensen per to kjeks. Mengden sjokoladespredning gitt daglig vil være ekvivalent med 20% av hver deltakers individuelle daglige kaloriinntak. Disse kaloribehovene vil bli etablert ved bruk av kostholdsretningslinjer for amerikanere (DGA) basert på deltakerens alder og kjønn
Annen: Cadbury melkesjokoladespredning
Kontroll (CTL) gruppe: Deltakere i denne gruppen vil motta en daglig snack som består av en isokalorisk mengde av en nøttefri, vegetabilsk oljebasert sjokoladespredning ("Cadbury Milk Chocolate") spredt mellom to vanlige usaltede saltkrekker ("Usaltede topper premium saltkrekker"). I likhet med peanøttsmørgruppen, vil sjokoladespredningen være begrenset til 16g per to kjeks, med ytterligere kjeks levert om nødvendig.
Andre navn:
  • Styre
  • CTL
  • Isocaloric spread
Eksperimentell: Almond Butter Condition
Participants in the ALB group will maintain their habitual diet supplemented with a once-daily snack of smooth natural almond butter (Creamy Richards 100% Almonds! Creamy Natural Almond Butter) spread between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers), with a maximum of 16g of almond butter per two crackers. The daily portion of almond butter will be individualized to provide 20% of each participant's estimated daily caloric needs, calculated using Dietary Guidelines for Americans (DGA) age- and sex-specific energy requirements.
Annen: Creamy Richards 100% Almonds! Creamy Natural Almond Butter
Almond Butter (ALB) Group: Participants in this group will receive a daily snack consisting of a personalized portion of smooth natural almond butter (Creamy Richards 100% Almonds! Creamy Natural Almond Butter) spread between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers). The amount of almond butter will be limited to 16g per two crackers; additional crackers will be provided if the personalized portion exceeds this limit.
Andre navn:
  • ALB
  • Almond Butter

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Gut Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal Samples
Tidsramme: Baseline (day 0), midpoint (week 4) and endpoint (week 8)
Freshly voided fecal samples will be collected and DNA extracted using the PowerFecal Pro DNA kit. The V3-V4 hypervariable region of the bacterial 16S ribosomal RNA gene will be PCR-amplified and sequenced. Sequences will be processed using the QIIME2 software package to assess microbial diversity (alpha and beta diversity) and taxonomic composition.
Baseline (day 0), midpoint (week 4) and endpoint (week 8)
Change in Oral Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Oral Swabs
Tidsramme: Baseline (day 0) and Endpoint (week 8)
Oral biofilm swabs (omniswab - tongue, palate, cheek/lip lining, gums) and unstimulated saliva will be collected in 5ml tubes. DNA will be extracted and the V3-V4 region of the bacterial 16S ribosomal RNA gene PCR-amplified and sequenced. Sequences will be processed using the QIIME2 software package to assess oral microbial diversity (alpha and beta diversity) and taxonomic composition.
Baseline (day 0) and Endpoint (week 8)
Change in Fecal Metabolome
Tidsramme: Baseline (day 0) and endpoint (week 8)
The endpoint of fecal metabolomics will be assessed by collecting fecal samples from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the feces. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular almond butter intake affects metabolic processes and gut health.
Baseline (day 0) and endpoint (week 8)
Change in Serum Metabolome
Tidsramme: Baseline (day 0) and endpoint (week 8)
The endpoint of serum metabolomics will be assessed by collecting blood serum from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the serum. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular almond butter intake affects metabolic processes and gut health.
Baseline (day 0) and endpoint (week 8)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Gut Transit Time
Tidsramme: Baseline (day 0) and endpoint (week 8)
Evaluate changes in gut transit time after almond butter or control snack consumption from baseline to final analysis, using a blue-dye capsule.
Baseline (day 0) and endpoint (week 8)
Change in Waist/Hip Circumference
Tidsramme: Baseline (week 0), midpoint (week 4), and endpoint (week 8)
Evaluate changes in waist and hip circumference (centimeters), as well as waist-hip ratio at each study visit before, after and during almond butter consumption, compared to a control snack.
Baseline (week 0), midpoint (week 4), and endpoint (week 8)
Change in Habitual Dietary Intake
Tidsramme: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Assess changes in habitual dietary intake via 3-day food logs, analyzed using nutrient analysis software (NDSR).
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Body Weight
Tidsramme: Baseline (day 0), midpoint (week 4), endpoint (week 8)
The endpoint of body weight (kg) will be measured at each visit to assess changes in weight before and after 8 week consumption of almond butter or a control snack spread.
Baseline (day 0), midpoint (week 4), endpoint (week 8)
Change in Urinary Melatonin
Tidsramme: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Changes in melatonin (urine metabolite 6-sulphatoxymelatonin) will be assessed before, during and after 8-week consumption of almond butter or control snack spread.
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Body Fat Percentage
Tidsramme: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Evaluate changes in body composition, including fat mass, expressed as a percentage of total weight (%). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during almond butter or control snack consumption.
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Lipid Profiles
Tidsramme: Baseline (day 0) and endpoint (week 8)
Relevant biomarkers are to be collected via venous blood samples to determine changes in cardiometabolic health including HDL, LDL, total cholesterol, and triglycerides. All will be expressed in units of mg/dL.
Baseline (day 0) and endpoint (week 8)
Change in Biomarkers of Inflammation
Tidsramme: Baseline (day 0) and endpoint (week 8)
Relevant biomarkers are to be collected via venous blood samples to determine changes in inflammation, including but not limited to C-reactive protein (CRP), IL-1 (Interleukin-1), IL-1 beta, IL-6, IL-10, IL-17, IL-23, Tumor Necrosis Factor Alpha (TNF-a), Interferon-gamma (IFN-Y). All will be expressed in units of pg/mL.
Baseline (day 0) and endpoint (week 8)
Change in Biomarkers of Intestinal Barrier Function
Tidsramme: Baseline (day 0) and endpoint (week 8)
Relevant biomarkers are to be collected via venous blood samples to determine changes in intestinal barrier function including LPS (lipopolysaccharides), LBP (lipopolysaccharide binding protein), CD14, Secretory IgA. All will be expressed in units of pg/mL.
Baseline (day 0) and endpoint (week 8)
Change in Lean Mass
Tidsramme: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Evaluate changes in body composition, including lean mass (kg). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during almond butter or control snack consumption.
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Biomarkers of Appetite
Tidsramme: Baseline (day 0) and endpoint (week 8)
Relevant biomarkers are to be collected via venous blood samples to determine changes in appetite including Insulin, Glucagon, glucagon-like peptide 1 (GLP-1), Adiponectin, Leptin, Ghrelin, and Peptide YY. All will be expressed in units of pg/mL.
Baseline (day 0) and endpoint (week 8)
Change in Rested, Seated Blood Pressure
Tidsramme: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
This outcome measure will measure changes in blood pressure taken at rest in the seated position at each visit, before during and after almond butter or control snack consumption, expressed as systolic over diastolic blood pressure in units of millimeters of mercury (mmHg).
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Fasting Blood glucose
Tidsramme: Baseline (day 0) and endpoint (week 8)
Venous blood samples will be collected to determine changes in fasting blood glucose (expressed as mg/DL).
Baseline (day 0) and endpoint (week 8)
Dietary Adherence
Tidsramme: Daily, baseline (day 0) through endpoint (week 8)
Assess adherence to the intervention and control snack throughout the study, as determined by dietary adherence logs kept by the participants each week. Adherence is expressed as a daily percent (%) consumption of their assigned snack
Daily, baseline (day 0) through endpoint (week 8)
Change in Total Body Water
Tidsramme: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Evaluate changes in body composition, including, total body water (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during almond butter or control snack consumption.
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Intracellular Fluid
Tidsramme: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Evaluate changes in body composition, including intracellular fluid (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during almond butter or control snack consumption.
Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Extracellular Fluid
Tidsramme: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Evaluate changes in body composition, including extracellular fluid (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during almond butter or control snack consumption.
Baseline (day 0), midpoint (week 4), and endpoint (week 8)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Florida State University

Samarbeidspartnere

Almond Board of California

Etterforskere

  • Hovedetterforsker: Ravinder Nagpal, PhD, Florida State University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

31. oktober 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

1. juni 2026

Først innsendt som oppfylte QC-kriteriene

5. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00007355

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Deidentified IPD will not be retain past three years, at the time of this submission the researchers does not plan to make IPD available

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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